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Active ingredient:
Available from:
ATC code:
Pharmaceutical form:
Administration route:
Prescription type:
Manufactured by:
Therapeutic group:
Therapeutic area:
Therapeutic indications:
Treatment of diabetes mellitus.
Authorization number:
122 67 30240 00
Authorization date:

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Patient Information leaflet Patient Information leaflet - Arabic


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העדוה העדוה

לע לע

הרמחה הרמחה



עדימ עדימ

ןולעב )תוחיטב ןולעב )תוחיטב



אפור אפור

ןכדועמ( ןכדועמ(












NovoMix 30 FlexPen – 127- 24-30599-00

NovoMix 30 Penfill – 122- 67-30240-00







מ"עב ספוט







תושקובמה קרפ

ןולעב טסקט

יחכונ טסקט




Posology, dosage & administration

Special Warnings and Special

Precautions for Use

Insulin antibodies

Insulin administration may cause insulin antibodies to

form. In rare cases, the presence of such insulin

antibodies may necessitate adjustment of the insulin dose

in order to correct a tendency to hyper- or


Interaction with Other

Medicaments and Other Forms

of Interaction

Fertility, pregnancy and


Adverse events


ובש ,ןולעה

נמוסמ תו


שקובמה תו










)ןולעב( עבצב

שי .הנוש







םוקימב .טסקטה רבעוה





ב רשואו קדבנ ונכותו תואירבה דרשמ י"ע עבקנ הז ןולע טמרופ רבמטפס




NovoMix® 30 Penfill® 100 units/ml suspension for injection in cartridge



1 ml of the suspension contains 100 units soluble insulin aspart*/protamine-crystallised insulin

aspart* in the ratio 30/70 (equivalent to 3.5 mg). 1 cartridge contains 3 ml equivalent to 300 units.

*Insulin aspart is produced in Saccharomyces cerevisiae by recombinant DNA technology.

For the full list of excipients, see section 6.1.



Suspension for injection.

The suspension is cloudy, white and aqueous.




Therapeutic indications

NovoMix® 30 is indicated for treatment of diabetes mellitus.


Posology and method of administration


The potency of insulin analogues, including insulin aspart, is expressed in units, whereas the potency

of human insulin is expressed in international units.

NovoMix® 30 dosing is individual and determined in accordance with the needs of the patient. Blood

glucose monitoring and insulin dose adjustments are recommended to achieve optimal glycaemic


In patients with type 2 diabetes, NovoMix® 30 can be given as monotherapy. NovoMix® 30 can also

be given in combination with oral antidiabetic medicinal products if the patient's blood glucose is

inadequately controlled with oral antidiabetic medicinal products alone. For patients with type 2

diabetes, the recommended starting dose of NovoMix® 30 is 6 units at breakfast and 6 units at dinner

(evening meal). NovoMix® 30 can also be initiated once daily with 12 units at dinner (evening meal).

When using NovoMix® 30 once daily, it is generally recommended to move to twice daily when

reaching 30 units by splitting the dose into equal breakfast and dinner doses. If twice daily dosing

with NovoMix® 30 results in recurrent daytime hypoglycaemic episodes, the morning dose can be

split into morning and lunchtime doses (thrice daily dosing).

The following titration guideline is recommended for dose adjustments:

Pre-meal blood glucose level

NovoMix® 30 dose


< 4.4 mmol/l

< 80 mg/dl

- 2 units

4.4 – 6.1 mmol/l

80 – 110 mg/dl

6.2 – 7.8 mmol/l

111 – 140 mg/dl

+ 2 units

7.9 – 10 mmol/l

141 – 180 mg/dl

+ 4 units

> 10 mmol/l

> 180 mg/dl

+ 6 units

The lowest of the three previous days’ pre-meal blood glucose levels should be used. The dose should

not be increased if hypoglycaemia occurred within these days. Dose adjustments can be made once a

week until target HbA

is reached. Pre-meal blood glucose levels should be used to evaluate the

adequacy of the preceding dose.

In patients with type 1 diabetes, the individual insulin requirement is usually between 0.5 and

1.0 unit/kg/day. NovoMix® 30 may fully or partially meet this requirement.

Adjustment of dose may be necessary if patients undertake increased physical activity, change their

usual diet or during concomitant illness.

Special populations

Older people (≥ 65 years old)

NovoMix® 30 can be used in older patients; however there is limited experience with the use of

NovoMix® 30 in combination with oral antidiabetic medicinal products in patients older than

75 years.

In older patients, glucose monitoring should be intensified and the insulin aspart dose adjusted on an

individual basis.

Renal and hepatic impairment

Renal or hepatic impairment may reduce the patient’s insulin requirements.

In patients with renal or hepatic impairment, glucose monitoring should be intensified and the insulin

aspart dose adjusted on an individual basis.

Paediatric population

NovoMix® 30 can be used in adolescents and children aged 10 years and above when premixed

insulin is preferred. There is limited clinical experience with NovoMix® 30 in children aged 6–

9 years (see section 5.1).

No data are available for NovoMix® 30 in children below 6 years of age.

Transfer from other insulin medicinal products

When transferring a patient from biphasic human insulin to NovoMix® 30, start with the same dose

and regimen. Then titrate according to individual needs (see the titration guideline in the table above).

Close glucose monitoring is recommended during the transfer and in the initial weeks thereafter (see

section 4.4).

Method of administration

NovoMix® 30 is a biphasic suspension of the insulin analogue, insulin aspart. The suspension

contains rapid-acting and intermediate-acting insulin aspart in the ratio 30/70.

NovoMix® 30 is for subcutaneous administration only.

NovoMix® 30 is administered subcutaneously by injection in the thigh or in the abdominal wall. If

convenient, the gluteal or deltoid region may be used. Injection sites should always be rotated within

the same region in order to reduce the risk of lipodystrophy. The influence of different injection sites

on the absorption of NovoMix® 30 has not been investigated. The duration of action will vary

according to the dose, injection site, blood flow, temperature and level of physical activity.

NovoMix® 30 has a faster onset of action than biphasic human insulin and should generally be given

immediately before a meal. When necessary, NovoMix® 30 can be given soon after a meal.

Administration with an insulin delivery system

NovoMix® 30 Penfill® is designed to be used with Novo Nordisk insulin delivery systems and

NovoFine® or NovoTwist® needles.

NovoMix® 30 Penfill® is accompanied by a package leaflet with detailed instructions for use to be




Hypersensitivity to the active substance or to any of the excipients (see section 6.1).


Special warnings and precautions for use

NovoMix® 30 must not be administered intravenously, as it may result in severe hypoglycaemia.

Intramuscular administration should be avoided. NovoMix® 30 is not to be used in insulin infusion


Before travelling between different time zones, the patient should seek the doctor’s advice since this

may mean that the patient has to take the insulin and meals at different times.


Inadequate dosing or discontinuation of treatment, especially in type 1 diabetes, may lead to

hyperglycaemia and diabetic ketoacidosis. Usually, the first symptoms of hyperglycaemia develop

gradually over a period of hours or days. They include thirst, increased frequency of urination,

nausea, vomiting, drowsiness, flushed dry skin, dry mouth, loss of appetite as well as acetone odour of

breath. In type 1 diabetes, untreated hyperglycaemic events eventually lead to diabetic ketoacidosis,

which is potentially lethal.


Omission of a meal or unplanned, strenuous physical exercise may lead to hypoglycaemia.

Hypoglycaemia may occur if the insulin dose is too high in relation to the insulin requirement. In case

of hypoglycaemia or if hypoglycaemia is suspected, NovoMix® must not be injected. After

stabilisation of the patient’s blood glucose, adjustment of the dose should be considered (see sections

4.2, 4.8 and 4.9).

Compared with biphasic human insulin, NovoMix® 30 may have a more pronounced glucose

lowering effect up to 6 hours after injection. This may have to be compensated for in the individual

patient through adjustment of insulin dose and/or food intake.

Patients whose blood glucose control is greatly improved, e.g. by intensified insulin therapy, may

experience a change in their usual warning symptoms of hypoglycaemia and should be advised

accordingly. Usual warning symptoms may disappear in patients with longstanding diabetes.

Tighter control of glucose levels can increase the potential for hypoglycaemic episodes and therefore

require special attention during dose intensification as outlined in section 4.2.

Since NovoMix® 30 should be administered in immediate relation to a meal, the rapid onset of action

should be considered in patients with concomitant diseases or treatment where a delayed absorption

of food might be expected.

Concomitant illness, especially infections and feverish conditions, usually increases the patient’s

insulin requirements. Concomitant diseases in the kidney, liver or affecting the adrenal, pituitary or

thyroid gland can require changes in the insulin dose.

When patients are transferred between different types of insulin medicinal products, the early warning

symptoms of hypoglycaemia may change or become less pronounced than those experienced with

their previous insulin.

Transfer from other insulin medicinal products

Transferring a patient to another type or brand of insulin should be done under strict medical

supervision. Changes in strength, brand (manufacturer), type, origin (animal insulin, human insulin or

insulin analogue) and/or method of manufacture (recombinant DNA versus animal source insulin)

may result in the need for a change in dose. Patients transferred to NovoMix® 30 from another type

of insulin may require an increased number of daily injections or a change in dose from that used with

their usual insulin medicinal products. If an adjustment is needed, it may occur with the first dose or

during the first few weeks or months.

Injection site reactions

As with any insulin therapy, injection site reactions may occur and include pain, redness, hives,

inflammation, bruising, swelling and itching. Continuous rotation of the injection site within a given

area reduces the risk of developing these reactions. Reactions usually resolve in a few days to a few

weeks. On rare occasions, injection site reactions may require discontinuation of NovoMix® 30.

Combination of NovoMix® with pioglitazone

Cases of cardiac failure have been reported when pioglitazone was used in combination with insulin,

especially in patients with risk factors for development of cardiac heart failure. This should be kept in

mind if treatment with the combination of pioglitazone and NovoMix® is considered. If the

combination is used, patients should be observed for signs and symptoms of heart failure, weight gain

and oedema. Pioglitazone should be discontinued if any deterioration in cardiac symptoms occurs.

Insulin antibodies

Insulin administration may cause insulin antibodies to form. In rare cases, the presence of such insulin

antibodies may necessitate adjustment of the insulin dose in order to correct a tendency to hyper- or



Interaction with other medicinal products and other forms of interaction

A number of medicinal products are known to interact with the glucose metabolism.

The following substances may reduce the patient’s insulin requirements:

Oral antidiabetic medicinal products, monoamine oxidase inhibitors (MAOI), beta-blockers,

angiotensin converting enzyme (ACE) inhibitors, salicylates, anabolic steroids and sulfonamides.

The following substances may increase the patient’s insulin requirements:

Oral contraceptives, thiazides, glucocorticoids, thyroid hormones, sympathomimetics, growth

hormone and danazol.

Beta-blockers may mask the symptoms of hypoglycaemia.

Octreotide/lanreotide may either increase or decrease the insulin requirement.

Alcohol may intensify or reduce the hypoglycaemic effect of insulin.


Fertility, pregnancy and lactation


There is limited clinical experience with NovoMix® 30 in pregnancy.

Animal reproduction studies have not revealed any differences between insulin aspart and human

insulin regarding embryotoxicity or teratogenicity.

In general, intensified blood glucose control and monitoring of pregnant women with diabetes are

recommended throughout pregnancy and when contemplating pregnancy. Insulin requirements usually

fall in the first trimester and increase subsequently during the second and third trimesters. After

delivery, insulin requirements return rapidly to pre-pregnancy levels.


There are no restrictions on treatment with NovoMix® 30 during breast-feeding. Insulin treatment of

the nursing mother presents no risk to the baby. However, the NovoMix® 30 dose may need to be



Animal reproduction studies have not revealed any differences between insulin aspart and human

insulin regarding fertility.


Effects on ability to drive and use machines

The patient’s ability to concentrate and react may be impaired as a result of hypoglycaemia. This may

constitute a risk in situations where these abilities are of special importance (e.g. driving a car or

operating machinery).

Patients should be advised to take precautions to avoid hypoglycaemia while driving or operating a

machine. This is particularly important in those who have reduced or absent awareness of the warning

signs of hypoglycaemia or have frequent episodes of hypoglycaemia. The advisability of driving or

operating a machine should be considered in these circumstances.


Undesirable effects

a. Summary of the safety profile

Adverse reactions observed in patients using NovoMix® are mainly due to the pharmacological effect

of insulin aspart.

The most frequently reported adverse reaction during treatment is hypoglycaemia. The frequencies of

hypoglycaemia vary with patient population, dose regimens and level of glycaemic control, please see

section c below.

At the beginning of the insulin treatment, refraction anomalies, oedema and injection site reactions

(pain, redness, hives, inflammation, bruising, swelling and itching at the injection site) may occur.

These reactions are usually of transitory nature. Fast improvement in blood glucose control may be

associated with acute painful neuropathy, which is usually reversible. Intensification of insulin

therapy with abrupt improvement in glycaemic control may be associated with temporary worsening

of diabetic retinopathy, while long-term improved glycaemic control decreases the risk of progression

of diabetic retinopathy.

b. Tabulated list of adverse reactions

The adverse reactions listed below are based on clinical trial data and classified according to

MedDRA frequency and System Organ Class. Frequency categories are defined according to the

following convention: Very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to

< 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000); not known (cannot be estimated from

the available data).

Immune system disorders

Uncommon – Urticaria, rash, eruptions

Very rare – Anaphylactic reactions*

Metabolism and nutrition


Very common – Hypoglycaemia*

Nervous system disorders

Rare – Peripheral neuropathy (painful neuropathy)

Eye disorders

Uncommon – Refraction disorders

Uncommon – Diabetic retinopathy

Skin and subcutaneous tissue


Uncommon – Lipodystrophy*

General disorders and

administration site conditions

Uncommon – Oedema

Uncommon – Injection site reactions

* see section c.

c. Description of selected adverse reactions

Anaphylactic reactions:

The occurrence of generalised hypersensitivity reactions (including generalised skin rash, itching,

sweating, gastrointestinal upset, angioneurotic oedema, difficulties in breathing, palpitation and

reduction in blood pressure) is very rare but can potentially be life-threatening.


The most frequently reported adverse reaction is hypoglycaemia. It may occur if the insulin dose is

too high in relation to the insulin requirement. Severe hypoglycaemia may lead to unconsciousness

and/or convulsions and may result in temporary or permanent impairment of brain function or even

death. The symptoms of hypoglycaemia usually occur suddenly. They may include cold sweats, cool

pale skin, fatigue, nervousness or tremor, anxiousness, unusual tiredness or weakness, confusion,

difficulty in concentrating, drowsiness, excessive hunger, vision changes, headache, nausea and


In clinical trials, the frequency of hypoglycaemia varied with patient population, dose regimens and

level of glycaemic control. During clinical trials, the overall rates of hypoglycaemia did not differ

between patients treated with insulin aspart compared to human insulin.


Lipodystrophy (including lipohypertrophy, lipoatrophy) may occur at the injection site. Continuous

rotation of the injection site within the particular area reduces the risk of developing these reactions.

d. Paediatric population

Based on post-marketing sources and clinical trials, the frequency, type and severity of adverse

reactions observed in the paediatric population do not indicate any differences to the broader

experience in the general population.

e. Other special populations

Based on post-marketing sources and clinical trials, the frequency, type and severity of adverse

reactions observed in older patients and in patients with renal or hepatic impairment do not indicate

any differences to the broader experience in the general population.

f. Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It

allows continued monitoring of the benefit/risk balance of the medicinal product.

Any suspected adverse events should be reported to the Ministry of Health according to the National

Regulation by using an online form

( or by email (adr@MOH.HEALTH.GOV.IL).



A specific overdose for insulin cannot be defined, however, hypoglycaemia may develop over

sequential stages if too high doses relative to the patient’s requirement are administered:

Mild hypoglycaemic episodes can be treated by oral administration of glucose or sugary

products. It is therefore recommended that the diabetic patient always carries sugar-containing


Severe hypoglycaemic episodes, where the patient has become unconscious, can be treated with

glucagon (0.5 to 1 mg) given intramuscularly or subcutaneously by a trained person, or with

glucose given intravenously by a healthcare professional. Glucose must be given intravenously,

if the patient does not respond to glucagon within 10 to 15 minutes. Upon regaining

consciousness, administration of oral carbohydrates is recommended for the patient in order to

prevent a relapse.




Pharmacodynamic properties

Pharmacotherapeutic group: Drugs used in diabetes. Insulins and analogues for injection,

intermediate- or long -acting combined with fast-acting. ATC code: A10AD05.

NovoMix® 30 is a biphasic suspension of 30% soluble insulin aspart (rapid-acting human insulin

analogue) and 70% protamine-crystallised insulin aspart (intermediate-acting human insulin


Mechanism of action and pharmacodynamic effects

The blood glucose lowering effect of insulin aspart is due to the facilitated uptake of glucose

following binding of insulin to receptors on muscle and fat cells and to the simultaneous inhibition of

glucose output from the liver.

NovoMix® 30 is a biphasic insulin, which contains 30% soluble insulin aspart. This has a rapid onset

of action, thus allowing it to be given closer to a meal (within zero to 10 minutes of the meal) when

compared to soluble human insulin. The crystalline phase (70%) consists of protamine-crystallised

insulin aspart, which has an activity profile similar to that of human NPH insulin.

When NovoMix® 30 is injected subcutaneously, the onset of action will occur within 10 to

20 minutes of injection. The maximum effect is exerted between 1 and 4 hours after injection. The

duration of action is up to 24 hours (Figure 1).



infusion rate

Figure 1: Activity profile of NovoMix® 30 (


) and biphasic human insulin 30 (---) in healthy


Clinical efficacy and safety

In a 3 month trial in patients with type 1 and type 2 diabetes, NovoMix® 30 showed equal control of

glycosylated haemoglobin compared to treatment with biphasic human insulin 30. Insulin aspart is

equipotent to human insulin on a molar basis. Compared to biphasic human insulin 30, administration

of NovoMix® 30 before breakfast and dinner resulted in lower postprandial blood glucose after both

meals (breakfast and dinner).

A meta-analysis including nine trials in patients with type 1 and type 2 diabetes showed that fasting

blood glucose was higher in patients treated with NovoMix® 30, than in patients treated with biphasic

human insulin 30.

In one study, 341 patients with type 2 diabetes were randomised to treatment with NovoMix® 30

either alone or in combination with metformin, or to metformin together with sulfonylurea. The

primary efficacy variable - HbA

after 16 weeks of treatment - did not differ between patients with

NovoMix® 30 combined with metformin and patients with metformin plus sulfonylurea. In this trial,

57% of the patients had baseline HbA

above 9%; in these patients, treatment with NovoMix® 30 in

combination with metformin resulted in significantly lower HbA

than metformin in combination

with sulfonylurea.

In one study, patients with type 2 diabetes, insufficiently controlled on oral hypoglycaemic agents

alone, were randomised to treatment with twice daily NovoMix® 30 (117 patients) or once daily

insulin glargine (116 patients). After 28 weeks of treatment following the dosing guideline outlined in

section 4.2, the mean reduction in HbA

was 2.8% with NovoMix® 30 (mean at baseline = 9.7%).

With NovoMix® 30, 66% and 42% of the patients reached HbA

levels below 7% and 6.5%,

respectively, and mean FPG was reduced by about 7 mmol/l (from 14.0 mmol/l at baseline to

7.1 mmol/l).

In patients with type 2 diabetes, a meta-analysis showed a reduced risk of overall nocturnal

hypoglycaemic episodes and major hypoglycaemia with NovoMix® 30 compared to biphasic human

insulin 30. The risk of overall daytime hypoglycaemic episodes was increased in patients treated with

NovoMix® 30.

Paediatric population

A 16-week clinical trial comparing postprandial glycaemic control of meal-related NovoMix® 30

with meal-related human insulin/biphasic human insulin 30 and bedtime NPH insulin was performed

in 167 patients aged 10 to 18 years. Mean HbA

remained similar to baseline throughout the trial in

both treatment groups, and there was no difference in hypoglycaemia rate with NovoMix® 30 or

biphasic human insulin 30.

In a smaller (54 patients) and younger (age range 6 to 12 years) population, treated in a double-blind,

cross-over trial (12 weeks on each treatment), the rate of hypoglycaemic episodes and the postprandial

glucose increase were significantly lower with NovoMix® 30 compared to biphasic human insulin 30.

Final HbA

was significantly lower in the biphasic human insulin 30 treated group compared with

NovoMix® 30.


Pharmacokinetic properties

Absorption, distribution and elimination

In insulin aspart, substitution of amino acid proline with aspartic acid at position B28 reduces the

tendency to form hexamers as observed with soluble human insulin. The insulin aspart in the soluble

phase of NovoMix® 30 comprises 30% of the total insulin; this is absorbed more rapidly from the

subcutaneous layer than the soluble insulin component of biphasic human insulin. The remaining 70%

is in crystalline form as protamine-crystallised insulin aspart; this has a prolonged absorption profile

similar to human NPH insulin.

The maximum serum insulin concentration is, on average, 50% higher with NovoMix® 30 than with

biphasic human insulin 30. The time to maximum concentration is, on average, half of that for

biphasic human insulin 30. In healthy volunteers, a mean maximum serum concentration of

32 pmol/l was reached about 60 minutes after a subcutaneous dose of 0.20 unit/kg body weight.

The mean half life (t

) of NovoMix® 30, reflecting the absorption rate of the protamine bound

fraction, was about 8–9 hours. Serum insulin levels returned to baseline 15–18 hours after a

subcutaneous dose. In type 2 diabetic patients, the maximum concentration was reached about

95 minutes after dosing, and concentrations well above zero for not less than 14 hours post-dosing

were measured.

Special populations

The pharmacokinetics of NovoMix® 30 have not been investigated in older patients or in patients

with renal or hepatic impairment.

Paediatric population

The pharmacokinetics of NovoMix® 30 have not been investigated in children or adolescents.

However, the pharmacokinetic and pharmacodynamic properties of soluble insulin aspart have been

investigated in children (6–12 years) and adolescents (13–17 years) with type 1 diabetes. Insulin

aspart was rapidly absorbed in both age groups, with similar t

as in adults. However, C


between the age groups, stressing the importance of the individual titration of insulin aspart.


Preclinical safety data

Non-clinical data reveal no special hazard for humans based on conventional studies of safety

pharmacology, repeated dose toxicity, genotoxicity and toxicity to reproduction and development.

In in vitro tests, including binding to insulin and IGF-1 receptor sites and effects on cell growth,

insulin aspart behaved in a manner that closely resembled human insulin. Studies also demonstrate

that the dissociation of binding to the insulin receptor of insulin aspart is equivalent to human insulin.




List of excipients





Disodium phosphate dihydrate

Sodium chloride

Protamine sulfate

Hydrochloric acid (for pH adjustment)

Sodium hydroxide (for pH adjustment)

Water for injections



In absence of compatibility studies, this medicinal product must not be mixed with other medicinal



Shelf life

Before opening: 2 years.

During use or when carried as a spare: The product can be stored for a maximum of 4 weeks.


Special precautions for storage

Before opening: Store in a refrigerator (2

C – 8

C). Keep away from the cooling element. Do not


During use or when carried as a spare: Store below 30

C. Do not refrigerate. Do not freeze.

Keep the cartridge in the outer carton in order to protect it from light.


Nature and contents of container

3 ml suspension in cartridge (type 1 glass) with a plunger (bromobutyl) and a rubber closure

(bromobutyl/polyisoprene). The cartridge contains a glass ball to facilitate resuspension.

Pack sizes of 5 and 10 cartridges. Not all pack sizes may be marketed.


Special precautions for disposal and other handling

Needles and NovoMix® 30 Penfill® must not be shared. The cartridge must not be refilled.

After removing NovoMix® 30 Penfill® from the refrigerator, it is recommended to allow NovoMix®

30 Penfill® to reach room temperature before resuspending the insulin as instructed for first time use.

Do not use this medicinal product if you notice that the resuspended liquid is not uniformly white,

cloudy and aqueous.

The necessity of resuspending the NovoMix® 30 suspension immediately before use is to be stressed

to the patient.

NovoMix® 30 which has been frozen must not be used.

The patient should be advised to discard the needle after each injection.

Any unused medicinal product or waste material should be disposed of in accordance with local




30 Penfill®

: 122-67-30240-00


Novo Nordisk A/S

Novo Allé

DK-2880 Bagsværd



Novo Nordisk Ltd.,

20 Hata’as St., Industrial Zone,

Kfar-Saba 4442520

The content of this leaflet was checked and approved by the Ministry of Health in September 2014.

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